Soy formulations and their use for promoting health

ABSTRACT

The present invention provides novel soy formulations comprising 3-23 milligrams of at least one isoflavone per gram of the formulation. The soy formulations may additionally comprise 0.4 to 1.2 grams of protein per gram of the formulation. In another aspect, the present invention provides novel soy formulations comprising diadzin, genistin and glycitin in a ratio of 3:1:2 to 3:4.5:1, preferably approximately 2:1:1 such that diadzin is a major isoflavone component. The present invention further provides dietary supplements and food products comprising a soy formulation of the present invention.  
     In another aspect the present invention provides pharmacological compositions comprising a soy formulation of the present invention. The pharmacological compositions may additionally comprise a medicinal composition.  
     Also disclosed are methods for promoting the health of an individual, preferably utilizing the soy formulations, dietary supplements, food products and/or pharmacological compositions of the present invention.

STATEMENT OF RELATED APPLICATIONS

[0001] The present application claims priority from U.S. provisionalpatent application serial No. 60/092,985, filed Jul. 16, 1998 and U.S.provisional patent application serial No. 60/105,797, filed Oct. 27,1999. The disclosure of each provisional application is herebyincorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates to soy formulations, dietarysupplements comprising the soy formulations and food products whichinclude the soy formulations and/or the dietary supplements. The presentinvention also relates to pharmacological compositions comprising thesoy formulation that may additionally comprise a medicinal composition.The present invention further relates to processes for producing soyformulations. In addition, the present invention relates to methods forpromoting the health of an individual utilizing the soy formulations,dietary supplements, food products and/or pharmacological compositionsof the present invention.

BACKGROUND

[0003] Soybeans include natural plant estrogens, known as phytoestrogensor isoflavones. These isoflavones are thought to bind to estrogenreceptors and thus exert an estrogenic response. Medical studies haveshown that isoflavones in soy protein have many beneficial interactionswith a variety of human tissues, are safe, cause no significantside-effects, and are the primary reason for many health benefits.Research has discovered in Asian countries like Japan, where thetraditional diet is high in soy protein, very few women complain aboutmenopausal symptoms, for example only 9% of Japanese women complainabout hot flashes. In addition, younger women have fewer menstrualperiods per year, and occurrences of some cancers (breast andendometrial), heart disease, and other chronic diseases are very low. Ithas been reported that Japanese women consume up to 200 mg ofisoflavones in their daily diet and have a lower incidence ofperimenstrual and menopausal symptoms than women in other culturesconsuming less daily dietary isoflavones. Previous studies usingisoflavone dosages of 76 mg per day report a 45% reduction in hotflashes in women after 12 weeks.

[0004] In addition to providing isoflavones, soybeans provide a sourceof protein. It is believed that the benefits from soy come from thephytoestrogens (isoflavones) other compounds such as lignans andsaponins, the soy protein itself and undoubtedly undiscovered compounds.

[0005] Several soy protein formulations are commercially available.Formulations produced exclusively from the whole soy bean generallyinclude 1-5 milligrams isoflavone per gram of the formulation and may beup to 90% protein. Formulations produced exclusively from the heart(center) of the soy bean generally include 24-36 milligram isoflavoneper gram of the formulation. Although tablets with concentrations of100-750 milligram isoflavones per gram are available, formulationshaving concentrations greater than 36 mg isoflavones per gram of theformulation are chemically extracted and modified and therefore are notconsidered natural.

[0006] Dietary levels of 60 milligrams, in particular 120-200 milligramsof isoflavones are difficult to achieve utilizing currently availablenatural soy protein formulations. To achieve a dietary level of greaterthan 60 milligrams, and in particular 120-200 milligrams of isoflavonesfrom soy formulations produced utilizing the whole soy bean couldrequire ingesting greater than 60 grams, in particular up to 120-200grams of soy protein. Intake of soy protein at this volume level tendsto cause digestive side effects such as bloating and constipation. Toachieve a dietary level of greater than 60 milligrams, preferably120-200 milligrams, of isoflavones from soy formulations producedutilizing the heart of the soy bean may require ingesting only 3 to 8grams of soy protein. However, with soy protein levels this low, theperson ingesting the formulation would be receiving minimal benefits andnutritional value from soy protein itself.

[0007] Accordingly, it would be advantageous to have a natural soyformulation having a milligram isoflavone to gram of the formulationratio falling between the ratios of natural soy formulations producedfrom the whole soybean and natural soy formulations produced from theheart of the soy bean.

[0008] It would also be advantageous to have dietary supplements thatinclude the natural soy formulations. In particular, it would beadvantageous to have dietary supplements which when ingested inreasonable amounts provide dietary isoflavone levels of greater than 60milligrams, preferably greater than 120 milligrams, for example 120-200milligrams or higher, e.g. greater than 200 milligrams. For certainapplications it may be advantageous to have dietary supplements or soyformulations that provide dietary isoflavone levels as high as 1500-2200milligrams, or greater.

[0009] Further, it would be advantageous to have food products thatinclude the natural soy formulations and/or the natural dietarysupplements. In particular, it would also be advantageous to have foodproducts which when ingested in reasonable amounts provide dietaryisoflavone levels of greater than 60 milligrams, preferably greater than120 milligrams, for example 120-200 milligrams, or higher, e.g. greaterthan 200 milligrams, up to 400-900 milligrams or greater. For certainapplications it may be advantageous to have food products, dietarysupplements or soy formulations that provide dietary isoflavone levelsas high as 1500-2200 milligrams, or greater.

[0010] These and other advantages are achieved by the present invention.

SUMMARY OF THE INVENTION

[0011] The present invention provides soy protein formulations (soyformulations), dietary supplements and food products (including medicalfoods) comprising the soy formulations and/or dietary supplements. Thepresent invention also provides pharmaceutical compositions.

[0012] A soy formulation of the present invention includes a higherconcentration of natural plant estrogens, referred to as isoflavones orphytoestrogens, per gram of the formulation, than currently available ina natural product. The soy formulation may further include protein,therefore providing a higher concentration of isoflavones per gram ofthe formulation, and per gram of protein in the formulation, thancurrently available in a natural product.

[0013] The isoflavone component of the soy formulation of the presentinvention may comprise naturally occurring isoflavones, including, butnot limited to: diadzin, genistin, and glycitin. In another aspect, thepresent invention provides soy formulations having diadzin as a majorisoflavone component.

[0014] A dietary supplement of the present invention comprises a soyformulation of the present invention. The dietary supplement may furthercomprise ingredients such as enzymes, a fiber source, vitamins and thelike.

[0015] A food product of the present invention comprises a soyformulation of the present invention and/or a dietary supplement of thepresent invention. The food product may further comprise additionalingredients.

[0016] A pharmaceutical composition of the present invention comprises asoy formulation of the present invention in a pharmacologicallyeffective amount. The compositions may additionally compriseprescription medicines. The combination may advantageously produce oneor more of the following effects:

[0017] 1) additive and/or synergistic benefits;

[0018] 2) reduction of the side effects and/or adverse effectsassociated with use of the prescription medicine in the absence of thesoy formulation; and/or

[0019] 3) the ability to lower the dosage of the prescription medicinein comparison to the amount of prescription medicine needed in theabsence of the soy formulation. Further advantages and possibleembodiments of a drug formulation of the present invention are discussedin detail below.

[0020] The soy formulations, dietary supplements, food products and/orpharmaceutical compositions of the present invention may advantageouslybe utilized in methods for promoting the health of an individual. Thesoy formulations, dietary supplements, food products and pharmaceuticalcompositions of the present invention may provide higher concentrationsof isoflavones than currently available soy products in a readilydigestible and absorbable form.

[0021] The soy formulations, dietary supplements, food products andpharmaceutical compositions of the present invention may also provideprotein. The isoflavones and/or protein provided by the soyformulations, dietary supplements, food products and pharmaceuticalcompositions of the present invention may provide numerous healthbenefits to an individual. In particular, the soy formulations, dietarysupplements, food products and pharmaceutical compositions of thepresent invention may be ingested in amounts that provide greater than60 milligrams, and in certain embodiments greater than 200 milligrams,or greater than 1800 milligrams, and that may additionally providegreater than 20 grams of protein, without the unpleasant side effectsindividuals have experienced with prior products.

[0022] Further details and advantages of the present invention areprovided in the following more detailed description.

DETAILED DESCRIPTION OF THE INVENTION

[0023] In one aspect, the present invention provides a soy formulationwhich includes a higher concentration of natural plant estrogens(referred to as isoflavones or phytoestrogens) per gram of protein thanpreviously available. A soy formulation of the present inventioncomprises 3 to 23 milligrams of at least one isoflavone per gram of theformulation. Preferably a soy formulation of the present inventioncomprises 5 to 15 milligrams of at least one isoflavone per gram of theformulation, more preferably, 6-9 milligrams of at least one isoflavoneper gram of the formulation.

[0024] In this aspect, the present invention provides a natural soyformulation comprising 3 to 23 milligrams of at least one isoflavone pergram of the formulation. In embodiments of the present invention thenatural soy formulation may comprise 5 to 15 milligrams of at least oneisoflavone per gram of the formulation, or 6 to 9 milligrams of at leastone isoflavone per gram of the formulation.

[0025] The isoflavone component of the soy formulation of the presentinvention preferably comprises naturally occurring isoflavones,including, but not limited to: diadzin, genistin, and/or glycitin.

[0026] In another aspect, the present invention provides a soyformulation comprising diadzin, genistin and glycitin and having adiadzin to genistin to glycitin ratio of between 3:1:2 and 3:4.5:1. Inother words, in this aspect the soy formulation comprises 3 partsdiadzin; 1 to 4.5 parts genistin; and 1 to 2 parts glycitin. Preferablya soy formulation of the present invention has a ratio of diadzin togenistin to glycitin of near or approximately 2:1:1, respectively, suchthat diadzin is the major isoflavone component.

[0027] Although the isoflavones discussed herein are discussed withreference to their glycone forms, the present invention may utilizeaglycone forms of isoflavones which may be digested and/or absorbed moreeasily by an individual. The aglycone form refers to glycone aftercleavage of the glucose subgroup.

[0028] In a further aspect, the soy formulations of the presentinvention comprise 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, morepreferably 0.6 to 0.8 grams of protein per gram of the formulation.Thus, an embodiment of a soy formulation of the present inventioncomprises:

[0029] 3 to 23 milligrams, preferably 5 to 15 milligrams, morepreferably, 6-9 milligrams of at least one isoflavone; and

[0030] 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably0.6 to 0.8 grams protein; per gram of the formulation.

[0031] The soy formulation may further include a plurality ofisoflavones, including diadzin, genistin and glycitin. In an embodimentthe soy formulation has a diadzin to genistin to glycitin ratio ofbetween 3:1:2 and 3:4.5:1. More preferably the soy formulation may havea ratio of diadzin to genistin to glycitin of near or approximately2:1:1, respectively, such that diadzin is the major isoflavonecomponent.

[0032] In yet a further aspect, the present invention provides a soyformulation produced by combining a first portion of higher isoflavoneconcentration soy product produced from the heart of the soy bean and asecond portion of lower isoflavone concentration soy product producedfrom the whole soy bean to achieve a soy formulation comprising 3 to 23milligrams of at least one isoflavone per gram of the formulation,preferably 5 to 15 milligrams of at least one isoflavone per gram of theformulation, more preferably, 6-9 milligrams of at least one isoflavoneper gram of the formulation. The isoflavone(s) may comprise diadzin,genistin and glycitin. The soy formulation thus obtained may furthercomprise 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably0.6 to 0.8 grams protein; per gram of the formulation. It is furtherpreferred that the soy formulation include the diadzin-genistin-glycitinratios discussed above.

[0033] A soy formulation of the present invention may take many forms.For example, the soy formulations of the present invention may be inpowder form. Alternatively, the soy formulations may be in tablet orliquid form. In addition, the soy formulations of the present inventionmay be included within a dietary supplement, or within food items, suchas nutrition bars, liquid drinks, cereals etc., in a food product of thepresent invention.

[0034] The soy formulations of the present invention may be utilized indietary supplements. In one aspect, a dietary supplement of the presentinvention comprises a soy formulation of the present invention. Thedietary supplement may comprise a soy formulation having one or more ofthe features described above. The amount of soy formulation utilized ina dietary supplement of the present invention will depend on the levelof isoflavones desired per serving or dose of the dietary supplement. Asfurther explained below, it is generally desirable for the dietarysupplement to provide greater than 60 milligrams of at least oneisoflavone per serving or dose. Thus, for example, a serving of adietary supplement of the present invention could comprise 10 grams of asoy formulation of the present invention comprising 7 milligrams of atleast one isoflavone per gram of the formulation, to provide 70milligrams of isoflavones. To achieve higher levels of isoflavones, thedietary supplement could include additional amounts of a soy formulationand/or a soy formulation having a higher level of isoflavones per gram.

[0035] Thus an embodiment of a dietary supplement comprises: a soyformulation comprising 3 to 23 milligrams, preferably 5 to 15milligrams, more preferably 6-9 milligrams of at least one isoflavoneper gram of the formulation wherein the amount of the soy formulation issufficient to provide greater than 60 milligrams of at least oneisoflavone per serving.

[0036] In another embodiment, a dietary supplement of the presentinvention comprises: a soy formulation comprising 3 to 23 milligrams,preferably 5 to 15 milligrams, more preferably, 6-9 milligrams of atleast one isoflavone per gram of the formulation; and 0.4 to 1.2 grams,preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams protein;per gram of the formulation; wherein the amount of the soy formulationis sufficient to provide greater than 60 milligrams of at least oneisoflavone per serving.

[0037] In a further embodiment, a dietary supplement of the presentinvention comprises: a soy formulation produced by combining a firstportion of higher isoflavone concentration soy product produced from theheart of the soy bean and a second portion of lower isoflavoneconcentration soy product produced from the whole soy bean to achieve asoy formulation comprising 3 to 23 milligrams of at least one isoflavoneper gram of the formulation, preferably 5 to 15 milligrams of at leastone isoflavone per gram of the formulation, more preferably, 6-9milligrams of at least one isoflavone per gram of the formulationwherein the amount of the soy formulation in the dietary supplement issufficient to provide greater than 60 milligrams of at least oneisoflavone per serving.

[0038] The isoflavone components and/or their ratios include thosediscussed above with reference to the soy formulations of the presentinvention. In particular embodiments of a dietary supplement of thepresent invention the amount of soy formulation utilized may be anamount sufficient to provide well above 60 milligrams of at least oneisoflavone per serving. In particular embodiments of a dietarysupplement the amount of soy formulation utilized may be an amountsufficient to provide 120-200 milligrams of at least one isoflavone perserving; greater than 200 milligrams of at least one isoflavone perserving; 400 to 900 milligrams of at least one isoflavone per serving;greater than 1800 milligrams of at least one isoflavone per serving; or1800 to 2200 milligrams of at least one isoflavone per serving.

[0039] In a still further embodiment, a dietary supplement of thepresent invention comprises: a soy formulation comprising diadzin,genistin and glycitin and having a diadzin to genistin to glycitin ratioof between 3:1:2 and 3:4.5:1. Preferably the soy formulation has a ratioof diadzin to genistin to glycitin of near or approximately 2:1:1,respectively, such that diadzin is the major isoflavone component. Inthis embodiment, the dietary supplement may provide any milligram levelof at least one isoflavone per serving, thus differing amounts of thesoy formulation may be utilized in the dietary supplement. In specificembodiments according to this aspect of a dietary supplement of thepresent invention the amount of soy formulation utilized is sufficientto provide greater than 60 milligrams of at least one isoflavone perserving. In particular embodiments of this dietary supplement the amountof soy formulation utilized may be an amount sufficient to provide120-200 milligrams of at least one isoflavone per serving; greater than200 milligrams of at least one isoflavone per serving; 400 to 900milligrams of at least one isoflavone per serving; greater than 1800milligrams of at least one isoflavone per serving; or 1800 to 2200milligrams of at least one isoflavone per serving.

[0040] In another aspect, a dietary supplement of the present inventioncomprises a soy formulation of the present invention and is furthercharacterized by comprising: 40 to 90%, preferably 70 to 90%, by weight,protein; 1 to 10%, preferably 1 to 5%, by weight, fat; and 1 to 59%,preferably 1 to 25%, by weight, carbohydrate. The analysis of protein,carbohydrate and fat levels may be accomplished utilizing conventionaltechniques.

[0041] In another aspect, a dietary supplement of the present inventionfurther comprises one or more of the following ingredients: digestiveenzymes, fibers, sweeteners, preservatives, vitamins, minerals and thelike, including but not limited to calcium phosphate, soy lecithin,salt, potassium, chloride, artificial and/or natural flavorings,carragenenen, carboxymethylcellulose, xantham gum, or milk solids.Suitable digestive enzymes include, but are not limited to: alphagalactosidase. Suitable fiber sources include, but are not limited to:psyllium. Suitable sweeteners include, but are not limited to, naturalsweeteners, including sucrose, dextrose, fructose and the like;artificial sweeteners including sucralose (Splenda), aspartame,saccharin and SinetK (acesulfurame K) and the like; and plant derivedsweeteners including stevia. The amounts of the one or more additionalingredients are such that the dietary supplement maintains the protein,carbohydrate and fat ratios set forth above.

[0042] A dietary supplement of the present invention may be in anydigestible form, including a powder, a tablet or in liquid form. Adietary supplement of the present invention may also be agglomeratedand/or otherwise treated to improve solubility, digestibility or otheraspects of the dietary supplement.

[0043] As will be understood by those of ordinary skill in the art, adietary supplement of the present invention may also include ingredientssimilar to those set forth below with respect to a food product of thepresent invention.

[0044] In a further aspect the present invention provides a digestiblefood product which includes greater than 60 milligrams of at least oneisoflavone per serving. In particular embodiments of this dietarysupplement the amount of soy formulation utilized may be an amountsufficient to provide 120-200 milligrams of at least one isoflavone perserving; greater than 200 milligrams of at least one isoflavone perserving; 400 to 900 milligrams of at least one isoflavone per serving;greater than 1800 milligrams of at least one isoflavone per serving; or1800 to 2200 milligrams of at least one isoflavone per serving.

[0045] In one aspect, a food product of the present invention comprisesa soy formulation of the present invention. The dietary supplement maycomprise a soy formulation having one or more of the features describedabove. The amount of soy formulation utilized in a food product of thepresent invention will depend on the level of isoflavones desired perserving of the food product. As further explained below, it is generallydesirable for the food product to provide greater than 60 milligrams ofat least one isoflavone per serving. Thus, for example, a serving of afood product of the present invention could comprise 8 grams of a soyformulation of the present invention comprising 9 milligrams of at leastone isoflavone per gram of the formulation, to provide 72 milligrams ofisoflavones. To achieve higher levels of isoflavones, the food productcould include additional amounts of a soy formulation and/or a soyformulation having a higher level of isoflavones per gram.

[0046] Thus an embodiment of a food product comprises: a soy formulationcomprising 3 to 23 milligrams, preferably 5 to 15 milligrams, morepreferably 6-9 milligrams of at least one isoflavone per gram of theformulation wherein the amount of the soy formulation is sufficient toprovide greater than 60 milligrams of at least one isoflavone perserving.

[0047] In another embodiment, a food product of the present inventioncomprises: a soy formulation comprising 3 to 23 milligrams, preferably 5to 15 milligrams, more preferably, 6-9 milligrams of at least oneisoflavone per gram of the formulation; and 0.4 to 1.2 grams, preferably0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams protein; per gram ofthe formulation; wherein the amount of the soy formulation is sufficientto provide greater than 60 milligrams of at least one isoflavone perserving.

[0048] In a further embodiment, a food product of the present inventioncomprises: a soy formulation produced by combining a first portion ofhigher isoflavone concentration soy product produced from the heart ofthe soy bean and a second portion of lower isoflavone concentration soyproduct produced from the whole soy bean to achieve a soy formulationcomprising 3 to 23 milligrams of at least one isoflavone per gram of theformulation, preferably 5 to 15 milligrams of at least one isoflavoneper gram of the formulation, more preferably, 6-9 milligrams of at leastone isoflavone per gram of the formulation wherein the amount of the soyformulation in the food product is sufficient to provide greater than 60milligrams of at least one isoflavone per serving.

[0049] The isoflavone components and/or their ratios include thosediscussed above with reference to the soy formulations of the presentinvention. In particular embodiments of a food product of the presentinvention the amount of soy formulation utilized may be an amountsufficient to provide well above 60 milligrams of at least oneisoflavone per serving. In particular embodiments of a food product theamount of soy formulation utilized may be an amount sufficient toprovide 120-200 milligrams of at least one isoflavone per serving;greater than 200 milligrams of at least one isoflavone per serving; 400to 900 milligrams of at least one isoflavone per serving; greater than1800 milligrams of at least one isoflavone per serving; or 1800 to 2200milligrams of at least one isoflavone per serving.

[0050] In a still further embodiment, a food product of the presentinvention comprises: a soy formulation comprising diadzin, genistin andglycitin and having a diadzin to genistin to glycitin ratio of between3:1:2 and 3:4.5:1. Preferably the soy formulation has a ratio of diadzinto genistin to glycitin of near or approximately 2:1:1, respectively,such that diadzin is the major isoflavone component. In this embodiment,the food product may provide any milligram level of at least oneisoflavone per serving, thus differing amounts of the soy formulationmay be utilized in the food product. In specific embodiments accordingto this aspect of a food product of the present invention the amount ofsoy formulation utilized is sufficient to provide greater than 60milligrams of at least one isoflavone per serving. In particularembodiments of this food product the amount of soy formulation utilizedmay be an amount sufficient to provide 120-200 milligrams of at leastone isoflavone per serving; greater than 200 milligrams of at least oneisoflavone per serving; 400 to 900 milligrams of at least one isoflavoneper serving; greater than 1800 milligrams of at least one isoflavone perserving; or 1800 to 2200 milligrams of at least one isoflavone perserving.

[0051] In another aspect a food product of the present invention maypreferably comprise:

[0052] 20 to 40%, by weight, protein, preferably provided by a soyformulation of the present invention;

[0053] 10 to 80%, by weight carbohydrate; and

[0054] 1 to 10%, by weight fat.

[0055] The food product may further comprise additional componentsincluding preservatives, flavorings, vitamins, minerals and the like,including but not limited to calcium phosphate, soy lecithin, salt,potassium, chloride, artificial and natural flavors, carragenenan,carboxymethylcellulose, xantham gum, water or milk. Among thecarbohydrates suitable for use in the present invention are includedfructose, glucose, dextrose, maltodextrin and corn syrup solids.

[0056] A food product of the present invention may also be produced in alower calorie form by substituting an artificial sweetener for all or aportion of the sugars. Suitable artificial sweeteners include sucralose(Splenda ), aspartame, saccharin and SinetK (acesulfurame K). Plantderived sweeteners such as stevia are also suitable.

[0057] A food product of the present invention may take many forms,including a powder for dispersing in a liquid, a tablet, a bar, liquiddrinks, a cereal etc. By way of example, a powdered food product of thepresent invention may comprise:

[0058] 30 to 32%, by weight a soy formulation of the present invention;

[0059] 55 to 57%, by weight carbohydrate;

[0060] 3 to 5%, by weight fat;

[0061] 0.2 to 1%, by weight calcium;

[0062] 0.2 to 1%, by weight phosphorous;

[0063] 0.1 to 0.7%, by weight sodium;

[0064] 0.2 to 1%, by weight potassium; and

[0065] include ingredients such as fructose, sugar, cocoa,.calciumphosphate, maltodextrin, soy lecithin, salt, potassium chloride,artificial flavor, carrageenan, carboxymethyl cellulose and xanthan gum,wherein the food product provides greater than 60 milligrams, preferably120-200 milligrams of at least one isoflavone per serving, preferably aplurality of isoflavones in the ratios discussed above.

[0066] A food product of the present invention may further includevitamins and minerals in an amount of up to 100% or more of therecommended daily allowance for each vitamin. In a preferred embodiment,a food product of the present invention may include 20-40% of therecommended daily allowance of most minerals.

[0067] In a further aspect, the present invention provides apharmacological composition comprising a soy formulation of the presentinvention. The amount of soy formulation utilized in a pharmacologicalcomposition of the present invention will depend on the level ofisoflavones desired per dose of the pharmacological composition. Asfurther explained below, it is generally desirable for thepharmacological composition to provide greater than 60 milligrams,preferably greater than 200 milligrams, more preferably greater than1800 milligrams, of at least one isoflavone per dose. Thus, for example,a serving of a pharmacological composition of the present inventioncould comprise 9 grams of a soy formulation of the present inventioncomprising 7 milligrams of at least one isoflavone per gram of theformulation, to provide 63 milligrams of isoflavones. To achieve higherlevels of isoflavones, the pharmacological composition could includeadditional amounts of a soy formulation and/or a soy formulation havinga higher level of isoflavones per gram.

[0068] Thus an embodiment of a pharmacological composition comprises: asoy formulation comprising 3 to 23 milligrams, preferably 5 to 15milligrams, more preferably 6-9 milligrams of at least one isoflavoneper gram of the formulation wherein the amount of the soy formulation issufficient to provide greater than 60 milligrams, preferably greaterthan 200 milligrams, more preferably greater than 1800 milligrams, of atleast one isoflavone per dose.

[0069] In another embodiment, a pharmacological composition of thepresent invention comprises: a soy formulation comprising 3 to 23milligrams, preferably 5 to 15 milligrams, more preferably, 6-9milligrams of at least one isoflavone per gram of the formulation; and0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to0.8 grams protein; per gram of the formulation; wherein the amount ofthe soy formulation is sufficient to provide greater than 60 milligrams,preferably greater than 200 milligrams, more preferably greater than1800 milligrams, of at least one isoflavone per dose.

[0070] In a further embodiment, a pharmacological composition of thepresent invention comprises: a soy formulation produced by combining afirst portion of higher isoflavone concentration soy product producedfrom the heart of the soy bean and a second portion of lower isoflavoneconcentration soy product produced from the whole soy bean to achieve asoy formulation comprising 3 to 23 milligrams of at least one isoflavoneper gram of the formulation, preferably 5 to 15 milligrams of at leastone isoflavone per gram of the formulation, more preferably, 6-9milligrams of at least one isoflavone per gram of the formulationwherein the amount of the soy formulation in the pharmacologicalcomposition is sufficient to provide greater than 60 milligrams,preferably greater than 200 milligrams, more preferably greater than1800 milligrams, of at least one isoflavone per dose.

[0071] The isoflavone components and/or their ratios include thosediscussed above with reference to the soy formulations of the presentinvention. In particular embodiments of a pharmacological composition ofthe present invention the amount of soy formulation utilized may be anamount sufficient to provide well above 60 milligrams of at least oneisoflavone per dose. In particular embodiments of a pharmacologicalcomposition the amount of soy formulation utilized may be an amountsufficient to provide 120-200 milligrams of at least one isoflavone perdose; greater than 200 milligrams of at least one isoflavone per dose;400 to 900 milligrams of at least one isoflavone per dose; greater than1800 milligrams of at least one isoflavone per dose; or 1800 to 2200milligrams of at least one isoflavone per dose.

[0072] In a still further embodiment, a pharmacological composition ofthe present invention comprises: a soy formulation comprising diadzin,genistin and glycitin and having a diadzin to genistin to glycitin ratioof between 3:1:2 and 3:4.5:1. Preferably the soy formulation has a ratioof diadzin to genistin to glycitin of near or approximately 2:1:1,respectively, such that diadzin is the major isoflavone component. Inthis embodiment, the pharmacological composition may provide anymilligram level of at least one isoflavone per dose, thus differingamounts of the soy formulation may be utilized in the pharmacologicalcomposition. In specific embodiments according to this aspect of apharmacological composition of the present invention the amount of soyformulation utilized is sufficient to provide greater than 60milligrams, preferably greater than 200 milligrams, more preferablygreater than 1800 milligrams, of at least one isoflavone per dose. Inparticular embodiments of this pharmacological composition the amount ofsoy formulation utilized may be an amount sufficient to provide 120-200milligrams of at least one isoflavone per dose; greater than 200milligrams of at least one isoflavone per dose; 400 to 900 milligrams ofat least one isoflavone per dose; greater than 1800 milligrams of atleast one isoflavone per dose; or 1800 to 2200 milligrams of at leastone isoflavone per dose.

[0073] As discussed above, and in detail below, a particularadvantageous feature of the present invention is that in another aspectthe present invention provides a pharmacological composition comprisinga soy formulation of the present invention and further comprising amedicinal composition. Suitable medicinal compositions include, but arenot limited to the medicinal compositions, drugs and/or prescriptiondrugs utilized in estrogen replacement therapy; hormone replacementtherapy; cholesterol lowering therapy; bone strengthening therapy;endometrial therapy; cancer therapy, including chemotherapy;alzeheimer's therapy; ulcer therapy; prostrate therapy; skin therapy;renal therapy; blood therapy; lymphatic therapy; lung therapy; nervoussystem therapy; diabetes therapy; eye therapy and the like. Thesemedicinal compositions include, but are not limited to, Premarin;Fosamax; Raloxifene; Tamoxifen; SERM's (selective estrogen receptormodulators) and other drugs known to those of ordinary skill in the art.

[0074] The amount of the medicinal composition utilized in thisembodiment of a pharmacological composition of the present invention isan amount sufficient to achieve the desired therapeutic effect whileminimizing side or adverse effects. In general the amount of themedicinal composition utilized in a pharmacological composition of thepresent invention will be the same or less than the amount utilized inconventional therapy in the absence of the soy formulation of thepresent invention.

[0075] An advantage of a pharmacological composition of the presentinvention comprising a soy formulation of the present invention and amedicinal composition is that the combination may have synergisticeffects. Therefore it may be possible to use a lesser amount of themedicinal composition in a pharmacological composition of the presentinvention than the amount traditionally utilized in the absence of a soyformulation of the present invention, while achieving substantially thesame desired therapeutic effects. This feature also may provide anadditional advantage of reducing side or adverse effects caused by themedicinal composition due to the lower amount of the medicinalcomposition utilized.

[0076] Further details, and specific examples of possible uses ofpharmacological compositions of the present invention that comprise asoy formulation of the present invention and a medicinal composition areset forth below with reference to the methods of the present invention.

[0077] Thus, an embodiment of a pharmacological composition comprises: asoy formulation comprising 3 to 23 milligrams, preferably 5 to 15milligrams, more preferably 6-9 milligrams of at least one isoflavoneper gram of the formulation wherein the amount of the soy formulation issufficient to provide greater than 60 milligrams, preferably greaterthan 200 milligrams, more preferably greater than 1800 milligrams, of atleast one isoflavone per dose; and a medicinal composition wherein theamount of the medicinal composition is sufficient to achieve a desiredtherapeutic effect.

[0078] In another embodiment, a pharmacological composition of thepresent invention comprises: a soy formulation comprising 3 to 23milligrams, preferably 5 to 15 milligrams, more preferably, 6-9milligrams of at least one isoflavone per gram of the formulation; 0.4to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8grams protein; per gram of the formulation; and a medicinal compositionwherein the amount of the soy formulation is sufficient to providegreater than 60 milligrams, preferably greater than 200 milligrams, morepreferably greater than 1800 milligrams, of at least one isoflavone perdose and wherein the amount of the medicinal composition is sufficientto achieve a desired therapeutic effect.

[0079] In a further embodiment, a pharmacological composition of thepresent invention comprises: a soy formulation produced by combining afirst portion of higher isoflavone concentration soy product producedfrom the heart of the soy bean and a second portion of lower isoflavoneconcentration soy product produced from the whole soy bean to achieve asoy formulation comprising 3 to 23 milligrams of at least one isoflavoneper gram of the formulation, preferably 5 to 15 milligrams of at leastone isoflavone per gram of the formulation, more preferably, 6-9milligrams of at least one isoflavone per gram of the formulationwherein the amount of the soy formulation in the pharmacologicalcomposition is sufficient to provide greater than 60 milligrams,preferably greater than 200 milligrams, more preferably greater than1800 milligrams, of at least one isoflavone per dose; and a medicinalcomposition wherein the amount of the medicinal composition issufficient to achieve a desired therapeutic effect.

[0080] The isoflavone components and/or their ratios include thosediscussed above with reference to the soy formulations of the presentinvention. In particular embodiments of a pharmacological composition ofthe present invention the amount of soy formulation utilized may be anamount sufficient to provide well above 60 milligrams of at least oneisoflavone per dose. In particular embodiments of a pharmacologicalcomposition the amount of soy formulation utilized may be an amountsufficient to provide 120-200 milligrams of at least one isoflavone perdose; greater than 200 milligrams of at least one isoflavone per dose;400 to 900 milligrams of at least one isoflavone per dose; greater than1800 milligrams of at least one isoflavone per dose; or 1800 to 2200milligrams of at least one isoflavone per dose.

[0081] In a still further embodiment, a pharmacological composition ofthe present invention comprises: a soy formulation comprising diadzin,genistin and glycitin and having a diadzin to genistin to glycitin ratioof between 3:1:2 and 3:4.5:1; and a medicinal composition wherein theamount of the medicinal composition is sufficient to achieve a desiredtherapeutic effect. Preferably the soy formulation has a ratio ofdiadzin to genistin to glycitin of near or approximately 2:1:1,respectively, such that diadzin is the major isoflavone component. Inthis embodiment, the pharmacological composition may provide anymilligram level of at least one isoflavone per dose, thus differingamounts of the soy formulation may be utilized in the pharmacologicalcomposition. In specific embodiments according to this aspect of apharmacological composition of the present invention the amount of soyformulation utilized is sufficient to provide greater than 60milligrams, preferably greater than 200 milligrams, more preferablygreater than 1800 milligrams, of at least one isoflavone per dose. Inparticular embodiments of this pharmacological composition the amount ofsoy formulation utilized may be an amount sufficient to provide 120-200milligrams of at least one isoflavone per dose; greater than 200milligrams of at least one isoflavone per dose; 400 to 900 milligrams ofat least one isoflavone per dose; greater than 1800 milligrams of atleast one isoflavone per dose; or 1800 to 2200 milligrams of at leastone isoflavone per dose.

[0082] Embodiments of a pharmacological composition of the presentinvention may further comprise a biologically compatible inert carriercomposition comprising one or more of the following ingredients: a gelcomposition; a cellulose composition; a starch; a glycol composition;hydroxypropyl methylcellulose; microcrystalline cellulose; polyethyleneglycol; and/or sodium lauryl sulfate. Other ingredients known in the artmay also be utilized in the carrier composition.

[0083] Among the advantages of the soy formulations, dietarysupplements, food products and pharmacological compositions of thepresent invention are that the soy formulations, dietary supplements,food products and pharmacological compositions may be utilized in themethods of the present invention to promote the health of an individual.In addition, the soy formulations, dietary supplements and food productsprovide a dietary means for providing beneficial amounts of anisoflavone, or a plurality of isoflavones, and protein to an individual,without requiring the individual ingests unpalatable or difficult todigest amounts of protein.

[0084] In addition to the soy formulations, dietary supplements, foodproducts and pharmacological compositions discussed above, the presentinvention provides methods for promoting the health of an individual. Amethod of the present invention for promoting the health of anindividual comprises having the individual ingest greater than 60milligrams, preferably greater than 120 milligrams, more preferably120-200 milligrams of at least one isoflavone per day. Embodiments of amethod of the present invention may further comprise having theindividual ingest greater than 200 milligrams of at least one isoflavoneper day.

[0085] Preferably the individual will ingest the isoflavones byingesting a soy formulation of the present invention, by ingesting adietary supplement of the present invention, by ingesting a food productof the present invention, or by ingesting a pharmacological compositionof the present invention. Thus, it is preferred that in a method of thepresent invention an individual ingests a soy formulation, a dietarysupplement, food product and/or pharmacological composition including asoy formulation, comprising 3 to 23 milligrams of at least oneisoflavone per gram of the formulation, more preferably 5 to 15milligrams of at least one isoflavone per gram of the formulation, evenmore preferably, 6-9 milligrams of at least one isoflavone per gram ofthe formulation. The soy formulation utilized in a method of the presentinvention may further comprise 0.4 to 1.2 grams, preferably 0.4 to 0.9grams, more preferably 0.6 to 0.8 grams protein; per gram of theformulation. The isoflavone(s) may comprise diadzin, genistin and/orglycitin. It is also preferred that in a method of the present inventionan individual ingest the isoflavones in a diadzin to genistin toglycitin ratio of between 3:1:2 and 3:4.5:1, preferably a ratio ofdiadzin to genistin to glycitin of near or approximately 2:1:1,respectively, such that diadzin is the major isoflavone component.

[0086] The present invention also provides methods for enhancing healthwhich include digesting a soy formulation of the present invention,and/or dietary supplements and/or food items and/or pharmacologicalcompositions which include a soy formulation of the present invention.

[0087] A method of the present invention may be utilized to promote thehealth of an individual by reducing menopausal like symptoms, includinghot flashes, pains and the like being experienced by the individual, forexample as the result of a hysterectomy, breast cancer or a recentpregnancy. A method of the present invention may be utilized to promotethe health of an individual by providing a dietary means of achievingthe effects achieved by estrogen therapies.

[0088] Methods of the present invention may also be utilized to promotethe health of an individual by reducing hot flashes, vaginalitching/dryness, irritability, mood swings, insomnia, night sweats,nervousness, headaches, and painful intercourse; soothing menstrualproblems like cramping, bloating, irritability, and weight gain and toincrease the time between menstrual periods (i.e., fewer periods peryear); decreasing fatigue by boosting energy levels and mood;maintaining healthy breast tissue, endometrial tissue, and othertissues; preserving a strong and healthy skeletal system (bones andjoints); and helping support a healthy heart, cardiovascular system, andcholesterol levels. Methods of the present invention may further beutilized to promote the health of an individual by minimizing theeffects of Alzheimer's type dementia, age-related loss of cognitivefunction, and alcoholism. Other potential uses of the methods of thepresent invention include: birth control (at higher doses); hormonereplacement therapy in combination with mammalian estrogens; breastcancer preventative; prostate cancer preventative; prevention and/ortreatment of headaches and migraine headaches; prevention and/ortreatment of acne and other skin conditions; improvement of sexualfunction; lessening effects of chronic fatigue syndrome; and weightloss.

[0089] As noted above, and in further detail below, methods of thepresent invention may be utilized to produce health benefits in anindividual by alleviating or minimizing symptoms of the followingconditions and/or providing health benefits in the following areas:

MENOPAUSE/PMS

[0090] Menopause symptoms like hot flushes, vaginal itching/dryness,irritability, mood swings, insomnia, night sweats.

[0091] Menopause-like symptoms.

[0092] Post-partum hot flushes.

[0093] Surgically-induced menopause symptoms (ie. oophorectomy).

[0094] PMS symptoms.

[0095] Normal menstrual complaints like cramping, bloating,irritability, and weight gain.

[0096] Abnormal vaginal bleeding of any cause.

[0097] Endometriosis, fibroids or other diseases where blocking estrogencould be beneficial.

[0098] In a particular embodiment of a method of the present inventionfor minimizing or alleviating symptoms of menopause/pms, the methodcomprises having an individual ingest a pharmacological composition ofthe present invention wherein the pharmacological composition comprisesa soy formulation comprising 3 to 23 milligrams, preferably 5 to 15milligrams, more preferably 6-9 milligrams of at least one isoflavoneper gram of the formulation wherein the amount of the soy formulation issufficient to provide greater than 60 milligrams, preferably greaterthan 200 milligrams, more preferably greater than 1800 milligrams, of atleast one isoflavone per dose; and a medicinal composition wherein theamount of the medicinal composition is sufficient to achieve a desiredtherapeutic effect.

[0099] A preferred medicinal composition for this embodiment is amedicinal composition for estrogen replacement therapy or hormonereplacement therapy (estrogen+progestins). Premarin is an example of amedicinal composition for this embodiment of the method of the presentinvention The combination of a soy formulation of the present inventionand a medicinal composition for hormone replacement therapy and/orestrogen replacement therapy may provide one or more of the followingadvantages:

[0100] 1) an additive benefit to heart and bone tissues while reducingmenopausal symptoms;

[0101] 2) reduced breast and endometrial proliferation; or

[0102] 3) a reduction in the amount of medicinal composition needed toachieve a therapeutic effect, for example less Premarin, resulting inlower cost to a patient and less risk.

HEART/CARDIOVASCULAR RELATED CONDITIONS

[0103] Lowering total cholesterol, LDL cholesterol, triglycerides andincreasing HDL cholesterol or other favorable improvement in lipidprofiles.

[0104] Lowering of blood pressure.

[0105] Prevention of myocardial infarction.

[0106] Prevention of second myocardial infarction.

[0107] Prevention or delaying restenosis of coronary bypass grafts orany other vascular grafts.

[0108] Prevention of stroke.

[0109] Improvement of cardiac stroke volume.

[0110] In a particular embodiment of a method of the present inventionfor benefiting heart/cardiovascular related conditions the methodcomprises having an individual ingest a pharmacological composition ofthe present invention wherein the pharmacological composition comprisesa soy formulation comprising 3 to 23 milligrams, preferably 5 to 15milligrams, more preferably 6-9 milligrams of at least one isoflavoneper gram of the formulation wherein the amount of the soy formulation issufficient to provide greater than 60 milligrams, preferably greaterthan 200 milligrams, more preferably greater than 1800 milligrams, of atleast one isoflavone per dose; and a medicinal composition wherein theamount of the medicinal composition is sufficient to achieve a desiredtherapeutic effect.

[0111] A preferred medicinal composition for this embodiment is Lipitoror another cholesterol lowering medication. The combination of a soyformulation of the present invention and a medicinal composition forcholesterol lowering may provide one or more of the followingadvantages:

[0112] 1) an additive benefit to heart and bone tissues while generatinga better lipid profile;

[0113] 2) a reduction in the amount of medicinal composition needed toachieve a therapeutic effect, for example less Lipitor, resulting inlower cost to a patient and less risk of liver abnormalities caused byLipitor.

BONE/SKELETAL SYSTEM CONDITIONS

[0114] Osteoporosis.

[0115] Hip fracture.

[0116] Quicker recovery after hip fracture surgery.

[0117] Disorders of the joints or cartilage.

[0118] Stimulation of growth and reduction of inflammation of connectivetissue/joints.

[0119] In a particular embodiment of a method of the present inventionfor minimizing or alleviating symptoms of menopause/pms, the methodcomprises having an individual ingest a pharmacological composition ofthe present invention wherein the pharmacological composition comprisesa soy formulation comprising 3 to 23 milligrams, preferably 5 to 15milligrams, more preferably 6-9 milligrams of at least one isoflavoneper gram of the formulation wherein the amount of the soy formulation issufficient to provide greater than 60 milligrams, preferably greaterthan 200 milligrams, more preferably greater than 1800 milligrams, of atleast one isoflavone per dose; and a medicinal composition wherein theamount of the medicinal composition is sufficient to achieve a desiredtherapeutic effect.

[0120] A preferred medicinal composition for this embodiment is amedicinal composition for strengthening bones, estrogen replacementtherapy or hormone replacement therapy (estrogen+progestins). Fosamax,Raloxifene and Premarin is an example of a medicinal composition forthis embodiment of the method of the present invention The combinationof a soy formulation of the present invention and a medicinalcomposition may provide one or more of the following advantages:

[0121] 1) an additive benefit to heart and bone tissues while reducingmenopausal symptoms;

[0122] 2) reduced breast and endometrial proliferation; or

[0123] 3) a reduction in the amount of medicinal composition needed toachieve a therapeutic effect, for example less Premarin, resulting inlower cost to a patient and less risk.

BREAST/PROSTRATE RELATED CONDITIONS

[0124] Prevention and treatment of any abnormal breast tissue including,but not limited to, fibrocystic disease, ductal hyperplasia, ductalcarcinoma in situ (DCIS), locally confined breast cancer or metastaticbreast cancer.

[0125] Hot flushes and other menopause-like symptoms caused by breastcancer treatment or preventative treatment (eg. hot flashes caused byuse of tamoxifen).

[0126] Improved quality/extension of life after diagnosis of breasttumor.

[0127] Early childhood treatment with isoflavones for prevention ofbreast cancer/prostate cancer later in life.

[0128] Reduces growth rate of cancerous tissue/cells.

[0129] Extension of life span after breast/prostate cancer.

[0130] In a particular embodiment of a method of the present inventionfor minimizing or alleviating symptoms of breast/prostrate relatedconditions, the method comprises having an individual ingest apharmacological composition of the present invention wherein thepharmacological composition comprises a soy formulation comprising 3 to23 milligrams, preferably 5 to 15 milligrams, more preferably 6-9milligrams of at least one isoflavone per gram of the formulationwherein the amount of the soy formulation is sufficient to providegreater than 60 milligrams, preferably greater than 200 milligrams, morepreferably greater than 1800 milligrams, of at least one isoflavone perdose; and a medicinal composition wherein the amount of the medicinalcomposition is sufficient to achieve a desired therapeutic effect.

[0131] A preferred medicinal composition for this embodiment is amedicinal composition for estrogen replacement therapy or hormonereplacement therapy (estrogen+progestins). Premarin is an example of amedicinal composition for this embodiment of the method of the presentinvention Other medicinal compositions include tamoxifen, raloxifene orSERM's. The combination of a soy formulation of the present inventionand a medicinal composition may provide one or more of the followingadvantages:

[0132] 1) an additive benefit to heart and bone tissues while having apreventive effect for breast cancer;

[0133] 2) reduced breast and endometrial proliferation; or

[0134] 3) a reduction in the amount of medicinal composition needed toachieve a therapeutic effect, for example less Premarin, resulting inlower cost to a patient and less risk.

ENDOMETRIUM

[0135] Prevention and treatment of endometrial abnormalities or disease.

[0136] Prevent endometrial hyperplasia/cancer caused by medications thatstimulate the endometrium (e.g. tamoxifen).

[0137] In a particular embodiment of a method of the present inventionfor preventing and/or minimizing endometrial conditions, the methodcomprises having an individual ingest a pharmacological composition ofthe present invention wherein the pharmacological composition comprisesa soy formulation comprising 3 to 23 milligrams, preferably 5 to 15milligrams, more preferably 6-9 milligrams of at least one isoflavoneper gram of the formulation wherein the amount of the soy formulation issufficient to provide greater than 60 milligrams, preferably greaterthan 200 milligrams, more preferably greater than 1800 milligrams, of atleast one isoflavone per dose; and a medicinal composition wherein theamount of the medicinal composition is sufficient to achieve a desiredtherapeutic effect.

[0138] A preferred medicinal composition for this embodiment is amedicinal composition comprising tamoxifen, raloxifene or SERM's. Thecombination of a soy formulation of the present invention and amedicinal composition may provide one or more of the followingadvantages:

[0139] 1) an additive benefit to heart and bone tissues while treatingendometrial conditions;

[0140] 2) reduced breast and endometrial proliferation, and preventionof endometrial hyperplasia/cancer (tamoxifen has been shown to promoteformation of endometrial cancers, the soy formulation of the presentinvention may reduce this risk); or

[0141] 3) a reduction in the amount of medicinal composition needed toachieve a therapeutic effect, for example less Premarin, resulting inlower cost to a patient and less risk.

HEAD/BRAIN SYMPTOMS

[0142] Prevention and treatment of Alzheimer's or other diseases ofcognition.

[0143] Macular degeneration.

[0144] Migraine/vascular-related headaches.

[0145] Anxiety, nervousness, depression or other similar affectivedisorders

[0146] Hereditary hemorrhagic talengiectasia (HHT).

[0147] Male pattern baldness and female baldness.

[0148] Improvement in cognitive function.

[0149] In a particular embodiment of a method of the present inventionfor minimizing or alleviating head/brain symptoms, the method compriseshaving an individual ingest a pharmacological composition of the presentinvention wherein the pharmacological composition comprises a soyformulation comprising 3 to 23 milligrams, preferably 5 to 15milligrams, more preferably 6-9 milligrams of at least one isoflavoneper gram of the formulation wherein the amount of the soy formulation issufficient to provide greater than 60 milligrams, preferably greaterthan 200 milligrams, more preferably greater than 1800 milligrams, of atleast one isoflavone per dose; and a medicinal composition wherein theamount of the medicinal composition is sufficient to achieve a desiredtherapeutic effect.

[0150] A preferred medicinal composition for this embodiment is amedicinal composition for Alzheimer's disease. The combination of a soyformulation of the present invention and a medicinal composition mayprovide one or more of the following advantages:

[0151] 1) an additive benefit to heart and bone tissues while treatingAlzheimer's symptoms;

[0152] 2) a reduction in the amount of medicinal composition needed toachieve a therapeutic effect, resulting in lower cost to a patient andless risk.

GASTROINTESTINAL (GI) TRACT CONDITIONS

[0153] Any disorders of the gastrointestinal tract such as:

[0154] Constipation.

[0155] Peptic ulcers or other ulcers.

[0156] Gastroesophageal reflux (GERD).

[0157] Any inflammatory bowel diseases such as ulcerative colitis orCrohn's disease.

[0158] Cancers of the GI tract such as colon cancer.

SKIN/FACE CONDITIONS

[0159] Prevention of acne.

[0160] Treatment/reduction/prevention of facial wrinkling and sagging.

[0161] Prevention/treatment of skin cancers.

[0162] Growth stimulation of hair and nails.

[0163] Prevention/restoration of hair loss (men/women)

[0164] Promotion of strong nails and hair.

[0165] As understood by those of ordinary skill in the art, theseskin/face conditions are often undesired side effects of a treatmentprotocol utilizing prescription drugs. Use of a pharmcologicalcomposition of the present invention comprising a soy formulation of thepresent invention and the prescription drug may advantageously reducethese conditions while also acheiving the desired therapeutic effect.

KIDNEY RELATED CONDITIONS

[0166] Prevention of disease, particularly diabetic nephropathies,polycystic kidney disease.

[0167] Improvement in kidney function such as increasing glomerularfiltration rate (GFR).

[0168] Management of lipid abnormalities secondary to renal disease.

LUNG AND BREATHING RELATED CONDITIONS

[0169] Improvement in elasticity.

[0170] Treatment of cancers.

ADDITIONAL PROSTATE/URINARY TRACT CONDITIONS

[0171] Any prostate disorders.

[0172] Prevention/treatment of bladder or other reproductive tractcancers in men and women.

[0173] Prevention of death from prostate cancer (Japanese men have equalincidence of prostate cancer, but death rate is very low).

[0174] Treatment/prevention of symptoms of benign prostatic hyperplasia(BPH) (urgency, frequency, painful ejaculation, nocturia, etc.) andprostate cancer.

[0175] Prevention of prostrate cancer progression.

[0176] Treatment for impotence.

[0177] Lowering prostate specific antigen (PSA).

[0178] Lowering circulating dihydrotestosterone (DHT) levels.

[0179] Inhibition of 5-alpha reductase.

[0180] In a particular embodiment of a method of the present inventionfor acheiving these health benefits, the method comprises having anindividual ingest a pharmacological composition of the present inventionwherein the pharmacological composition comprises a soy formulationcomprising 3 to 23 milligrams, preferably 5 to 15 milligrams, morepreferably 6-9 milligrams of at least one isoflavone per gram of theformulation wherein the amount of the soy formulation is sufficient toprovide greater than 60 milligrams, preferably greater than 200milligrams, more preferably greater than 1800 milligrams, of at leastone isoflavone per dose; and a medicinal composition wherein the amountof the medicinal composition is sufficient to achieve a desiredtherapeutic effect.

[0181] A preferred medicinal composition for this embodiment is amedicinal composition for estrogen replacement therapy or hormonereplacement therapy (estrogen+progestins). Premarin is an example of amedicinal composition for this embodiment of the method of the presentinvention The combination of a soy formulation of the present inventionand a medicinal composition for hormone replacement therapy and/orestrogen replacement therapy may provide one or more of the followingadvantages:

[0182] 1) an additive benefit to heart and bone tissues while reducingmenopausal symptoms;

[0183] 2) reduction of estrogenic side effects (enlarged breasts,decreased libido, feminization)

[0184] 3) reduced breast and endometrial proliferation; or

[0185] 4) a reduction in the amount of medicinal composition needed toachieve a therapeutic effect, for example less Premarin, resulting inlower cost to a patient and less risk.

IMMUNE SYSTEM CONDITIONS

[0186] Autoimmune/rheumatological disorders such as sarcoidosis,rheumatoid arthritis, lupus.

[0187] Boosting immune system of immunocompromised individuals.

REPRODUCTIVE SYSTEM CONDITIONS

[0188] Increasing length of time between menstrual cycles.

[0189] Birth control at higher doses.

[0190] Increased fertility by causing regular menstrual cycles.

NERVOUS SYSTEM CONDITIONS

[0191] Treatment of pain, minimizing pain associated withtrauma/surgery.

[0192] Treatment/minization of nerve damage associated withtrauma/surgery.

[0193] It has been found that having mice ingest a soy formulationshortens time of neuropathies induced by nerve damage. Thus, forexample, a breast cancer patient could take soy before surgery tominimize nerve damage/potential pain from surgery.

[0194] As understood by those of ordinary skill in the art, nervoussystem conditions/pain are often treated utilizing prescription drugs.Use of a pharmcological composition of the present invention comprisinga soy formulation of the present invention and the prescription drug mayadvantageously provide the foregoing advantages thus reducing the amountof prescription drug necessary to acheive the desired therapeuticeffect.

DIABETES ASSOCIATED DISEASES

[0195] Prevention of diabetic retinopathies.

[0196] Prevention/treatment of heart disease (see e.g. above).

[0197] Prevention/treatment of nerve damage (see e.g. above).

[0198] Prevention/treatment of kidney disease (see e.g. above).

EYE CONDITIONS

[0199] Prevention of cataracts and macular degeneration.

GENERAL CONDITIONS

[0200] Improvement in sexual function—men and women.

[0201] Obesity.

[0202] Treatment for chronic fatigue syndrome and fibromyalgia.

[0203] Treatment of hypo/hyperglycemia.

[0204] The following example illustrates the production of a soyformulation of the present invention which may be utilized in a dietarysupplement and/or food product of the present invention and/or in amethod of the present invention.

EXAMPLE

[0205] The following is one example of a blend of a first portion ofhigher isoflavone concentration soy product from the heart of the beanand a second portion of lower isoflavone concentration soy product toachieve a natural soy formulation of the present invention having anmilligram isoflavone to gram soy protein ratio and a diadzin to genistinto glycitin ratio falling in the preferred ranges of the formulation ofthe present invention.

[0206] Soy product derived from the heart of the soybean producesrelatively higher concentrations of isoflavones (24-36 mg of isoflavonesper gram of protein). The higher isoflavone concentration soy productproduced from the heart of the soy bean used in the present inventioncontains Diadzin/Diadzein:Genistin/Genistein:Glycitin/Glycitein in theaverage ratios of 3.33:1.00:2.33, respectively (Table 1). Soy derivedfrom the whole soybean, such as found in soy product produced from thewhole soy beans, yields relatively lower concentrations of isoflavones(<1.0-5 mg isoflavones per gram of protein). The lower isoflavoneconcentration soy product used in the present invention containsDiadzin/Diadzein:Genistin/Genistein:Glycitin/Glycitein in the averageratios of 5.00:10.00:1.00, respectively (Table 1). One example of theinvention is a blend of approximately 4 grams of the higher isoflavoneconcentration soy product and approximately 18.4 grams of the lowerisoflavone concentration soy product resulting inDiadzin/Diadzein:Genistin/Genistein:Glycitin/Glycitein in theapproximate ratios of 2.00:1.00:1.00, respectively (Table 1). TABLE 1AVERAGE RATIOS OF ISOFLAVONES Higher isoflavone Lower isoflavoneconcentration concentration Blend ratios soy product soy product(approximate) Isoflavone (4 gm) (18.4 gm) (22.4 gm) Diadzin/Diadzein3.33 5.00 2.00 Genistin/Genistein 1.00 10.00 1.00 Glycitin/Glycitein2.33 1.00 1.00

[0207] Long soybean crop histories and multiple testings of isoflavoneconcentrations in soy product derived therefrom consistently demonstratethese average ratios of constituent isoflavone concentrations innaturally grown soybeans. Naturally grown soybeans are defined as thosewithout genetic modifications for isoflavone content. Actual ratios ofconstituent isoflavones in the final blended formulation depend on therelative amounts of higher isoflavone concentration soy product andlower isoflavone concentration soy product combined. The final soyformulation of the present invention preferably has an isoflavoneconcentration falling within the ranges discussed above. An example of afinal soy composition of the present invention is illustrated in Table2. TABLE 2 grams mg Isoflavones Protein per per Isoflavone gram gramTotal mg Concentration formulation formulation Isoflavones Higher 424-36 96-144 Lower 18.4 <1.0-3.4   <18.4-62.56   Total 22.4 6-9<114.4-206.56  

[0208] Although the invention has been described with reference toparticular embodiments and features, other similar embodiments andfeatures may be utilized to obtain similar results. Variations andmodifications of the soy formulations, dietary supplements, foodproducts and methods of the present invention will be apparent to oneskilled in the art and the present disclosure is intended to cover allsuch modifications and equivalents within the scope of the followingclaims.

1. A natural soy formulation comprising 3 to 23 milligrams of at leastone isoflavone per gram of the formulation.
 2. The natural soyformulation of claim 1 wherein the soy formulation comprises 5 to 15milligrams of at least one isoflavone per gram of the formulation. 3.The natural soy formulation of claim 2 wherein the soy formulationcomprises 6 to 9 milligrams of at least one isoflavone per gram of theformulation.
 4. The natural soy formulation of claim 1 wherein theisoflavone comprises diadzin.
 5. The natural soy formulation of claim 4wherein the soy formulations comprises a plurality of isoflavonescomprising diadzin, genistin and glycitin.
 6. The natural soyformulation of claim 5 wherein the diadzin to genistin to glycitin ratiois between 3:1:2 and 3:4.5:1.
 7. A natural soy formulation comprisingisoflavones diadzin, genistin and glycitin wherein the diadzin togenistin to glycitin ratio is between 3:1:2 and 3:4.5:1.
 8. The naturalsoy formulation of claim 7 wherein the diadzin to genistin to glycitinratio is approximately 2:1:1.
 9. The natural soy formulation of claim 7wherein the isoflavones comprise their glycone forms.
 10. The naturalsoy formulation of claim 7 wherein the isoflavones comprise theiraglycone forms.
 11. A natural soy formulation comprising: 3 to 23milligrams of at least one isoflavone; and 0.4 to 1.2 grams protein; pergram of the formulation.
 12. The natural soy formulation of claim 11wherein the soy formulation comprises 5 to 15 milligrams of at least oneisoflavone per gram of the formulation.
 13. The natural soy formulationof claim 12 wherein the soy formulation comprises 6 to 9 milligrams ofat least one isoflavone per gram of the formulation.
 14. The natural soyformulation of claim 11 wherein the soy formulation comprises 0.4 to 0.9grams protein per gram of the formulation.
 15. The natural soyformulation of claim 13 wherein the soy formulation comprises 0.4 to 0.9grams protein per gram of the formulation.
 16. The natural soyformulation of claim 11 wherein the isoflavone comprises diadzin. 17.The natural soy formulation of claim 15 wherein the isoflavone comprisesdiadzin.
 18. The natural soy formulation of claim 15 wherein the soyformulations comprises a plurality of isoflavones comprising diadzin,genistin and glycitin.
 19. The natural soy formulation of claim 18wherein the diadzin to genistin to glycitin ratio is between 3:1:2 and3:4.5:1.
 20. A natural soy formulation produced by combining a firstportion of higher isoflavone concentration soy product produced from theheart of the soy bean and a second portion of lower isoflavoneconcentration soy product produced from the whole soy bean to achieve asoy formulation comprising 3 to 23 milligrams of at least one isoflavoneper gram of the formulation.
 21. The natural soy formulation of claim 20wherein the soy formulation further comprises 0.4 to 1.2 grams proteinper gram of the formulation.
 22. The natural soy formulation of claim 20wherein the soy formulation comprises 6 to 9 milligrams of at least oneisoflavone per gram of the formulation.
 23. The natural soy formulationof claim 21 wherein the soy formulation comprises 6 to 9 milligrams ofat least one isoflavone per gram of the formulation.
 24. The natural soyformulation of claim 23 wherein the soy formulation comprises 0.4 to 0.9grams protein per gram of the formulation.
 25. A dietary supplementcomprising the soy formulation of claim 1 wherein the amount of the soyformulation in the dietary supplement is sufficient to provide greaterthan 60 milligrams of at least one isoflavone per serving.
 26. A dietarysupplement comprising the soy formulation of claim 7 wherein the amountof the soy formulation in the dietary supplement is sufficient toprovide greater than 60 milligrams of at least one isoflavone perserving.
 27. A dietary supplement comprising the soy formulation ofclaim 11 wherein the amount of the soy formulation in the dietarysupplement is sufficient to provide greater than 60 milligrams of atleast one isoflavone per serving.
 28. A food product comprising the soyformulation of claim 1 wherein the amount of the soy formulation in thefood product is sufficient to provide greater than 60 milligrams of atleast one isoflavone per serving.
 29. A food product comprising the soyformulation of claim 7 wherein the amount of the soy formulation in thefood product is sufficient to provide greater than 60 milligrams of atleast one isoflavone per serving.
 30. A food product comprising the soyformulation of claim 11 wherein the amount of the soy formulation in thefood product is sufficient to provide greater than 60 milligrams of atleast one isoflavone per serving.
 31. A pharmcological compositioncomprising the soy formulation of claim 1 wherein the amount of the soyformulation in the pharmacological composition is sufficient to providegreater than 60 milligrams of at least one isoflavone per dose.
 32. Thepharmacological composition of claim 31 further comprising a medicinalcomposition in an amount per dose sufficient to produce a desiredtherapeutic effect.
 33. The pharmacological composition of claim 32wherein the medicinal composition comprises: Premarin; Fosamax;Raloxifene; Tamoxifen; or an SERM.
 34. A pharmcological compositioncomprising the soy formulation of claim 7 wherein the amount of the soyformulation in the pharmacological composition is sufficient to providegreater than 60 milligrams of at least one isoflavone per dose.
 35. Thepharmacological composition of claim 34 further comprising a medicinalcomposition in an amount per dose sufficient to produce a desiredtherapeutic effect.
 36. The pharmacological composition of claim 35wherein the medicinal composition comprises: Premarin; Fosamax;Raloxifene; Tamoxifen; or an SERM.
 37. A pharmcological compositioncomprising the soy formulation of claim 11 wherein the amount of the soyformulation in the pharmacological composition is sufficient to providegreater than 60 milligrams of at least one isoflavone per dose.
 38. Thepharmacological composition of claim 37 further comprising a medicinalcomposition in an amount per dose sufficient to produce a desiredtherapeutic effect.
 39. The pharmacological composition of claim 38wherein the medicinal composition comprises: Premarin; Fosamax;Raloxifene; Tamoxifen; or an SERM.
 40. A method for promoting the healthof an individual comprising having the individual ingest greater than 60milligrams of at least one isoflavone per day.
 41. The method of claim40 wherein the method comprises having the individual ingest 120 to 200milligrams of at least one isoflavone per day.
 42. The method of claim40 wherein the step of having the individual ingest greater than 60milligrams of at least one isoflavone per day comprises having theindividual ingest a soy formulation of claim
 1. 43. The method of claim40 wherein the step of having the individual ingest greater than 60milligrams of at least one isoflavone per day comprises having theindividual ingest a soy formulation of claim
 7. 44. The method of claim40 wherein the step of having the individual ingest greater than 60milligrams of at least one isoflavone per day comprises having theindividual ingest a soy formulation of claim
 11. 45. The method of claim40 wherein the step of having the individual ingest greater than 60milligrams of at least one isoflavone per day comprises having theindividual ingest a pharmacological composition of claim
 32. 46. Themethod of claim 40 wherein the step of having the individual ingestgreater than 60 milligrams of at least one isoflavone per day compriseshaving the individual ingest a pharmacological composition of claim 35.47. The method of claim 40 wherein the step of having the individualingest greater than 60 milligrams of at least one isoflavone per daycomprises having the individual ingest a pharmacological composition ofclaim
 38. 49. The method of claim 40 wherein the promoting of the healthof the individual comprises reducing menopausal like symptoms.
 50. Themethod of claim 49 wherein the menopausal like symptoms comprise hotflashes, vaginal itching, vaginal dryness, irritability, insomnia, nightsweats, headaches and/or mood swings.
 51. The method of claim 40 whereinthe promoting of the health of the individual comprises soothingmenstrual problems.
 52. The method of claim 40 wherein the promoting ofthe health of the individual comprises decreasing fatigue.
 53. Themethod of claim 40 wherein the promoting of the health of the individualcomprises reducing the effects of Alzheimer's type dementia.
 54. Themethod of claim 40 wherein the promoting of the health of the individualcomprises reducing the risk of breast cancer.